Kornimate/medical-research-clean huggingface dataset:
palliative short-course hypofractionated radiotherapy followed by chemotherapy in adenocarcinoma of the esophagus or esophagogastric junction trial - a phase ii clinical trial protocol.

Conditions: Adenocarcinoma of the Esophagus or Esophagogastric Junction

Summary: in this trial, patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent will be included. primary objective is to determine the rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil. the rate of improvement of dysphagia is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an improvement.


Eligibility criteria:
inclusion criteria: * patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent * any t, n and m * age: 18 years or older * who performance status ≤ 2 * life expectancy \> 3 months * dysphagia score \> 0 * adequate laboratory findings: hemoglobin \> 90 g/l, absolute neutrophil count * 1.0 10 9/l, platelets ≥ 75 x 10 9/l, bilirubin ≤ 1.5 x upper limit of normal (uln), alanine aminotransferase (alat) ≤ 5 x uln, creatinine ≤ 1.5 x uln * fertile men and women must use effective means of contraception * signed written informed concent * the patient must be able to comply with the protocol exclusion criteria: * prior treatment with self-expanding metal stent (sems), radiotherapy or chemotherapy for the present disease * clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months) unstable angina, new york heart association (nyha) grade iii-iv congestive heart failure * severe pulmonary disease e.g. pulmonary fibrosis * symptomatic peripheral neuropathy greater than grade 1 (ctcae v. 4.0) * known hypersensitivity to any contents of the study drugs * pregnancy ( positive pregnancy test) and/or breast feeding * any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial

Keywords: digestive system diseases esophageal cancer intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms endoscopic response fluorouracil metabolic response oxaliplatin radiotherapy
covid-19 impact on rheumatic patients

Conditions: COVID

Summary: a study to assess the impact of coronavirus disease 2019 (covid-19) pandemic on the attitude, behaviour and mental health of rheumatic patients and to compare them with healthy individuals.

to assess the impact of coronavirus disease 2019 (covid19) pandemic on the attitude, behaviour and mental health of rheumatic patients and to compare them with healthy individual. this is cross-sectional survey, 360 participants were included and divided into cases group composed of 180 patients with rheumatic diseases and control group composed of 180 healthy people. data were collected via a self-administered structured questionnaire (google form) which was sent to participants via social networks and emails to different rheumatic patients and healthy individuals. mental health was measured by the five-item brief symptom rating scale (bsrs-5). conclusion: mental health should be addressed in the same manner we deal with the infectious disease itself, being of no less importance. it is essential for mental health professionals provide psychological support to vulnerable populations, including the infected and chronically ill patients and their families, individuals, communities and health care workers.

Eligibility criteria:
inclusion criteria: * adult patient with diagnosed rheumatic disease exclusion criteria: -

Keywords: rheumatic patients covid-19 behaviour mental health
nutritional enhancement in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is characterized by increased oxidative stress which aggravates airway and systemic inflammation. previous studies suggested that dietary factors such as ample consumption of antioxidants might have beneficial effects in lung function in copd patients. the investigators' primary aim is therefore to investigate prospectively whether a nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and vegetables, would significantly affect lung function decline in copd patients compared to a free diet. methods: this is a 3-year prospective study, incorporating a run-in period of six months and outpatient clinic visits, scheduled every 6 months. consecutive sampling was used to recruit 120 patients with copd. at baseline and at each visit all patients were evaluated for respiratory symptoms, dietary habits, medication used and pulmonary function. patients will be randomized either to a diet based on increased consumption of foods containing antioxidants (fresh fruits and vegetables), intervention group (ig) or, to a free diet, control group (cg). the investigators hypothesize that the results from the study will suggest that a diet rich in antioxidants may be associated with improvement in lung function in copd patients. in this respect dietary interventions should be considered in the management of copd.


Eligibility criteria:
inclusion criteria: * diagnosis of copd according to the gold definition\* * ability to perform spirometry. (\*pauwels ra, buist as, calverley pm, et al. global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. nhlbi/who global initiative for chronic obstructive lung disease (gold). workshop summary. am j respir crit care med 2001; 163(5):1256-1276.) exclusion criteria: * a history of lung cancer, bronchial asthma or other respiratory disease * continuous use of systemic steroids more than 30 days prior was used as exclusion criteria

Keywords: lung function chronic obstructive pulmonary disease antioxidants
metagenomic analysis of human gut microbiota in patients with metabolic diseases including diabetes

Conditions: Type 2 Diabetes Mellitus; Dyslipidemias

Summary: microbiota is important for immunology, hormonal and metabolic homeostasis in human and could influence on developing diabetes and obesity. recent studies investigates microbiota by metagenomic sequencing, however, the composite of microbiota and its metabolic role has not been fully determined. metagenomics and microbiome analysis could early diagnose metabolic disorders and suggest treatment options for metabolic diseases. in this study, the investigators investigate the composite of microbiota and deduct basic information for treatment models using metagenomic sequencing.

1. cross-section study: normal/prediabetes/drug naïve type2 diabetes: compare microbiota using metagenomic sequencing among three groups. 2. observational prospective study: metformin/sodium glucose co-transporter 2 (sglt2) inhibitor/ezetimibe: compare microbiota using metagenomic sequencing before and after drug treatment.

Eligibility criteria:
inclusion criteria: * normal group: body mass index \[bmi\]\<23kg/m2, without diabetes mellitus history * prediabetes group: fasting blood glucose ≥100 mg/dl and \<126 mg/dl or postprandial blood glucose ≥140 mg/dl and \<200 mg/dl * type 2 diabetes according to ada(american diabetes association) guideline (1) fasting blood glucose ≥126 mg/dl, (2) random blood glucose ≥200 mg/dl and with typical diabetes symptoms, (3) glycated hemoglobin a1c ≥6.5% and anti-hypoglycemic drug naive * patients with type 2 diabetes, metformin monotherapy, sglt2 inhibitor monotherapy * patients with dyslipidemia, ezetimibe therapy exclusion criteria: * inflammatory bowel disease (crohn's disease, ulcerative colitis) * history of stomach, small intestine or colon resection operation * on antibiotics therapy
improving adherence to prescribing guidelines for cholesterol lowering in hospitalized diabetic patients

Conditions: Diabetes; Dyslipidemia

Summary: we hypothesize that when compared to usual care a greater proportion of hospitalized diabetic patients who are candidates for cholesterol lowering will be discharged with a prescription for a statin if their physicians are contacted by a pharmacist to discuss treatment guidelines.


Eligibility criteria:
inclusion criteria: * hospitalized patients with diabetes * ldl \>= 100 exclusion criteria: * terminal illness * pregnancy * intolerance or contraindication to statin
evaluating benefit of peptide based diet in obese hen patients

Conditions: Obesity

Summary: the purpose of this study is to assess the effects of a low energy, high protein tube feeding formula on body weight in tube fed patients who are obese. it will also assess study formula tolerance as well as impact of the study formula on lean body mass, blood pressure, blood sugar and lipids.


Eligibility criteria:
inclusion criteria: * home enteral nutrition (hen) patient receiving at least 90% of energy needs from enteral nutrition. * bmi \> 30. * history of stroke. * weight stable over the past month. exclusion criteria: * diagnosis of cancer undergoing active treatment (chemotherapy, radiation, immunotherapy). * life expectancy of less than 6 months. * stage iv or higher kidney disease (gfr \< 30).

Keywords: tube feeding obesity body mass
haecs are preliminarily applied in allogeneic hematopoietic stem cell transplantation

Conditions: Leukemia

Summary: haecs are preliminarily applied in allogeneic hematopoietic stem cell transplantation

establishment of clinical applicable human amniotic epithelial cell products and its preliminary application in allogeneic hematopoietic stem cell transplantation

Eligibility criteria:
inclusion criteria: * leukemia patients with allogeneic hsct * kfs score \>90 * after transplantation, the patient was implanted (peripheral blood neutrophil absolute value \>500/ul for 3 consecutive days) * no uncontrolled infection after transplantation * activity ii above agvhd * patients agreed to participate in the study exclusion criteria: * patients refused to participate in the study * patients have poor compliance * has received hormone therapy * patients had serious heart, lung, liver, kidney and other vital organs damage * researchers believe that patients who are not suitable for observation study
pilot evaluation of a new galyfilcon a lens prototype and enfilcon a lens

Conditions: Myopia

Summary: the purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon a prototype lenses against avaira® lenses when worn as daily wear for seven (7) days.


Eligibility criteria:
inclusion criteria: * the subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study. * the subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00d. * any cylinder power must be ≤ -0.75d. * the subject must have visual acuity best correctable to 20/25+3 or better for each eye. * the subject must read and sign the statement of informed consent. * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: * ocular or systemic allergies or disease which might interfere with contact lens wear. * systemic disease or use of medication which might interfere with contact lens wear. * clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. * clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * pregnancy or lactation. * diabetes. * infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv). * habitual contact lens type is toric, multifocal, or is worn as extended wear.
is the 6-minute walking test combined with an imu useful in stroke rehabilitation assessment?

Conditions: Stroke; Physical Therapy Modalities; Gait Analysis

Summary: this observational study aims at the evaluation of stroke subjects with an inertial measurement unit (imu) during the execution of a 6-minute walking test, to evaluate the associations between the kinematic parameters retrieved trough an imu and the classical outcome scales. moreover compare the stroke subjects with age-matched healthy subjects, and detect the differences of gait kinematic.


Eligibility criteria:
stroke group inclusion criteria: * age \>= 18; * mini-mental state examination ≥ 24; * ability to provide written informed consent and to understand the test instructions; * presence of a single stroke. exclusion criteria: * more than one stroke; . stroke area other than the cerebral cortex; * concomitant neurological disease and pathology of the locomotor system. healthy group inclusion criteria: - volunteers with age similar to the stroke group subjects exclusion criteria: - any disease that could affect the performance in terms of metres walked and quality of gait.
autologous adipose mesenchymal stem cell transplantation in the treatment of patients with hemifacial spasm

Conditions: Injury of Facial Nerve, Unspecified Side, Initial Encounter

Summary: main purpose：in the face of listening to nerve injury at early stage, utilizing autologous adipose stem cell transplantation in the treatment of makes the acceptance micro vascular decompression hemifacial spasm patients to nerve function to obtain a better recovery. secondary purpose ：to clarify the efficacy of stem cells in the treatment of cranial nerve dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction. cases in group：appearing on the surface of microvascular decompression for hemifacial spasm to decrease neural electrophysiological index of patients research design：single center, prospective, randomized, double-blind, controlled observation index：facial nerve clinical score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal fluid index evaluation of therapeutic effect：facial nerve function evaluation (house-brackmann classification, facial nerve function classification scale sfgs), facial nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric measurement safety evaluation：clear evaluation of hemifacial spasm and micro vascular decompression were listening to nerve in intracranial segment wrapped around the autologous fat stem cell therapy overall safety and evaluation methods including adverse events, laboratory tests, vital signs, electrocardiogram.


Eligibility criteria:
inclusion criteria: 1. the age of 18 \~ 80 years old; 2. no surgical contraindications, accept facial nerve microvascular decompression surgery; 3. to enter into the group's informed consent and sign the consent form for clinical research. 4. patients with preoperative facial nerve electrophysiology examination without facial paralysis 5. patients with preoperative electrical testing without hearing impairment exclusion criteria: 1. patients with poor compliance; 2. major surgical complications and interruption of treatment; 3. brain magnetic resonance examination or blood test results abnormal and clinical significance; 4. clinical trials of other drugs within 30 days; 5. the unintended side effects;
comparison of two electrotherapy methods on chronic low back pain

Conditions: Low Back Pain, Mechanical

Summary: the purpose of this study is; to compare the effects of interferential current therapy (if) applied in addition to conventional physical therapy on pain, functional status and quality of life compared to pulsed electromagnetic field therapy (pemf) in patients with chronic low back pain.

the low back is the most common region for musculoskeletal pain. many factors play a role in the etiology of low back pain. a certain etiological factor or pathophysiological mechanism cannot be found in 85-90% of the patients. approximately 80% of those living in industrialized countries experience low back pain in some part of their lives. 10% of low back pain becomes chronic. it is believed that 1% of workforce losses are due to low back pain. this type of pain often occurs when the back muscles, tendons and ligaments are exposed to stress or strain. mechanical back pains are chronic pain that often affects the lower part of the spine and radiates to the gluteal region. since daily activities such as leaning, turning, lifting, standing and sitting for a long time increase the pain, the intensity of the pain increases during the day. interferential current (if) therapy is obtained from two medium frequency currents and is applied by delivering a low frequency current (for example 20 to 100 hz) to the tissue. pulsed electromagnetic field (pemf) therapy, which is among physical therapy methods, is frequently used in the treatment of knee, hip and spine osteoarthritis symptoms. it is thought that magnetic field therapy improves the oxygen utilization of the cells and the erythrocytes release more oxygen under the influence of the magnetic field, thus having a positive effect on the circulatory system

Eligibility criteria:
inclusion criteria: * being diagnosed with nonspecific low back pain * symptom onset with more than 3 months exclusion criteria: * history of surgery on low back region * structural deformity on the low back region * radiculopathy * tumor or malignancy * any skin condition that prevents usage of electrotherapy * having a pace maker or other types of implants on the low back, pelvis and thoracic region

Keywords: rehabilitation electric stimulation therapy quality of life pain
alogliptin tablets special drug use surveillance "type 2 diabetes mellitus: combination therapy with thiazolidinediones"

Conditions: Type 2 Diabetes Melitus

Summary: the purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.

this is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting. participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. the planned sample size is 1,000 subjects. the usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Eligibility criteria:
inclusion criteria: * patients who did not adequately respond to the following treatment • treatment with thiazolidinediones in addition to diet therapy and exercise therapy exclusion criteria: * patients contraindicated for nesina 1. patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of nesina is not appropriate.) 2. patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of nesina is not appropriate.) 3. patients with a history of hypersensitivity to any ingredient of nesina

Keywords: drug therapy
effectiveness of subtalar arthroereisis with endorthesis for pediatric flexible flat foot

Conditions: Flatfoot; Pediatric ALL

Summary: pediatric flexible flatfoot is sometimes asymptomatic but it can also cause physical impairment, pain, and difficulty walking. we evaluate the radiographic effectiveness of intervention of subtalar arthroereisis with endorthesis for pediatric flexible flatfoot with final follow-up at skeletal maturity.


Eligibility criteria:
inclusion criteria: * males and females * age ≥ 14 years at the time of the visit * patients who underwent subtalar endothesis for the treatment of the pediatric flexible flatfoot from january 2011 to march 2015. exclusion criteria: * age \<14 years at the time of the visit * patients with comorbidities that make it difficult to return to the hospital for consultation or who have removed the device for discomfort * female patients who do not exclude (by self-declaration, as clinical practice) a state of pregnancy
diabetes inspired culinary education

Conditions: Type I Diabetes

Summary: the aim of this study is to assess the feasibility and efficacy of a community-based culinary nutrition education program (diabetes inspired culinary education, dice) on improving the diabetes management and dietary intake of 6-14 year old children with type i diabetes mellitus (tidm).


Eligibility criteria:
inclusion criteria: * children: 6-14 years old; diagnosed with type i diabetes within the past 5 years; english speaking * adults: primary caregiver of a 6-14 year old child diagnosed with type i diabetes within the past 5 years; english speaking exclusion criteria: -
high-dose (hd) methotrexate (mtx) induction chemotherapy followed by alternative hd mtx-based and hd cytarabine-based combination consolidation chemotherapy for newly diagnosed primary cns lymphoma; cisl 10-01 study

Conditions: CNS Lymphoma

Summary: the purpose of this study is to evaluate the complete response (cr) rate after hd-mtx induction chemotherapy followed by alternative hd mtx-based and hd cytarabine-based combination consolidation chemotherapy


Eligibility criteria:
inclusion criteria 1. histologically confirmed primary central nervous system (cns) lymphoma 2. previously untreated. patients treated with steroid alone are eligible. 3. performance status: ecog 0-3. 4. age; 20-70 5. adequate renal function: estimated glomerular filtration rate (gfr) or estimated creatinine clearance (crcl) ≥ 50 ml/min 6. adequate liver functions: transaminase (ast/alt) \< 3 x upper normal value \& bilirubin \< 2 x upper normal value 7. adequate hematological function: hemoglobin ≥ 9 g/dl absolute neutrophil count (anc) ≥ 1,500/μl and platelet count ≥ 75,000/μl 8. at least one cerebral mass lesion on magnetic resonance imaging (mri) without involvement beyond the central nervous system (cns) 9. life expectancy \> 6 months 10. a negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are \< 1 years after the onset of menopause. 11. informed consent exclusion criteria 1. other subtypes nhl than primary central nervous system (cns) lymphoma 2. systemic involvement of primary cns lymphoma except leptomeningeal involvement 3. intraocular lymphoma 4. hiv (+) 5. any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 6. pregnant or lactating women, women of childbearing potential not employing adequate contraception 7. other serious illness or medical conditions * unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry * history of significant neurological or psychiatric disorders * active uncontrolled infection (viral, bacterial or fungal infection) 8. patients who have hbv (+) are eligible. however, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for hbv carrier to prevent hbv reactivation during whole treatment period. 9. concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.

Keywords: primary cns lymphoma mtx: methotrexate,leucovorin mvd: methotrexate,vincristine,dexamethasone via: vp-16 (etoposide),ifosfamide,mesna, cytarabine (ara-c) newly diagnosed primary cns lymphoma patients